- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00584402
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas & metastases) within the liver.
Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography
Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- UC Davis Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment
- Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter
- Patient is stable and is to be managed conservatively (i.e. non-surgically)
- 18 years of age or older
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Known or suspected cardiac shunt(s)
- Known sensitivity to octafluoropropane
- Pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contrast sonography
Contrast-enhanced sonography perflutren lipid microspheres
|
perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
Time Frame: 15 min
|
After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images.
The images pre-contrast and post contrast are compared visually.
One tumor per participant was analyzed.
|
15 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth
Time Frame: 15 min
|
Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type
|
15 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John P. McGahan, M.D., UC Davis School of Medicine Dept. of Radiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200715241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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